Recruiting

EFT

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06745947

Conditions

HIV Prevention

Eligibility Criteria

Sex: All

Age: 18 - 34

Healthy Volunteers: Accepted

Interventions

EFT

Study Details

Brief summary:

This research study is testing a new behavioral therapy called Episodic Future Thinking or EFT can help people reduce drug use and risky sexual behaviors while helping them adhere to their HIV prevention medication (PrEP). Participants will be randomly assigned to one of two groups. One group will receive standard care, which includes counseling on HIV prevention, drug use reduction, and sexual health. The other group will receive standard care plus a new program called Episodic Future Thinking (EFT), where participants will think about and plan for their future goals using a mobile app and counseling sessions. Study procedures that are not part of regular care include filling out surveys, providing blood, urine, and swab samples for testing, and using the EFT app.

Conditions

HIV Prevention

Study ID

NCT06745947

Start date

Mar 3, 2025

Status verified date

Jun, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 34

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults 18 - 34 years of age
  • HIV negative (assessed via Rapid HIV Antibody Test)
  • Identify as gay, or bisexual
  • Recent (past 3 months) methamphetamine use
  • Currently prescribed and taking HIV PrEP medication
  • Self-reported HIV PrEP nonadherence in the past three months
  • Urine screen test for PrEP nonadherence
  • Self-reported condomless anal sex or a STI in the past three months
  • Able to attend all study visits
  • Fluent in English

Exclusion Criteria:

  • Currently receiving treatment for any substance use disorder,
  • HIV positive
  • Having a medical or psychiatric illness that in the opinion of the PI would interfere with study participation
  • Unable to provide informed consent
  • Unable to attend protocol directed study visits
  • Any plans that would preclude study completion (e.g. surgery, major medical treatments such as chemotherapy, incarceration, travel/moving out of San Antonio, Texas)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Episodic Future Thinking App

EFT is a behavioral economic intervention designed to improve decision-making by reducing delay discounting and improving demand. The EFT intervention will be administered through a combination of in-person counseling sessions and mobile health (mHealth) technology via an app platform.

no intervention: Control Group

Standard of Care: The standard of care group will receive brief information and supportive counseling around PrEP adherence, methamphetamine use reduction and engaging in safe sexual behaviors. Participants will also receive counseling on a topic of concern identified by the participant.

Interventions

EFT

Participants who meet the eligibility criteria will receive the EFT intervention, a cognitive training exercise designed to help them generate and visualize future events or goals. The intervention will be administered individually, in person, by a trained counselor

Primary outcome measure

  • Dried Blood Spot Analysis for PrEP adherence [ Time Frame: Day 1 to Day 180 ]
  • Urine Collection for Drug Screening [ Time Frame: Day 1 to Day 180 ]
  • Urine Collection for Sexually Transmitted Infections (STIs) [ Time Frame: Day 1 to Day 180 ]
  • Rectal Swab for STI testing [ Time Frame: Day 1 to Day 180 ]
  • Pre-exposure Prophylaxis (PrEP) Related Intentions [ Time Frame: Day 1 to Day 180 ]
  • PrEP Attitudes [ Time Frame: Day 1 to Day 180 ]
  • PrEP Stigma [ Time Frame: Day 1 to Day 180 ]
  • PrEP Self-efficacy [ Time Frame: Day 1 to Day 180 ]

Central Contacts and Locations

Central contacts

Emeka Okafor, PhD, MPH

210-450-7377okaforcn@uthscsa.edu

Locations

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Keywords

  • HIV negative
  • Methamphetamine use
  • HIV PrEP medication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-06-22.